Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide (Mebendazole)
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|ClinicalTrials.gov Identifier: NCT01729260|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2012
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed High-Grade Glioma||Drug: Mebendazole||Phase 1|
Glioblastoma (GBM) is the most common and aggressive brain cancer, and despite significant advances in treatment the majority of patients die within two years of diagnosis. During routine animal studies we serendipitously observed that fenbendazole, a benzimidazole antihelminthic used for pinworms, prevented tumor engraftment. Subsequent in vitro and in vivo experiments with benzimidazoles identified mebendazole as the drug having the best results in preclinical testing 1. In GBM cell lines, mebendazole displayed cytotoxicity with IC50s ranging from 0.1-0.3 μM. Mebendazole disrupted microtubule formation in GBM cells and it's in vitro activity was correlated with reduced tubulin polymerization. In two orthotopic mouse glioma models, one syngeneic and one xenograft, mebendazole significantly extended average survival up to 63% compared to untreated controls 1.
Mebendazole is an FDA approved antiparasitic agent with a well-established side effect and safety record and was effective in our animal models in dosing schedules that are documented as safe in humans. Therefore, mebendazole is a possible anti-cancer therapeutic with pre-clinical safety and efficacy and provides a promising opportunity for a clinical trial in patients with malignant gliomas.
In addition, a recently published case report case report from the University of Michigan documented successful long term control in metastatic adrenocortical adenocarcinoma using mebendazole 2. Mebendazole was well tolerated at 200 mg/day and used as the sole treatment after the patient failed other chemotherapies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide|
|Actual Study Start Date :||April 4, 2013|
|Actual Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2025|
All study participants will receive study drug; Mebendazole.
The mebendazole will be given by mouth three times every day on a 28 day cycle. it's in the form of 500 mg chewable tablets, to be taken with meals.
Other Name: Brand name: Vermox
- maximum tolerated dose (MTD) of mebendazole [ Time Frame: 8 months ]To determine the maximum tolerated dose (MTD) of mebendazole in combination with temozolomide (TMZ) given after surgery and the standard radiation and TMZ treatment in patients with newly diagnosed malignant gliomas.
- Overall Survival [ Time Frame: 10 years ]Overall survival in years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729260
|United States, Maryland|
|The Johs Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Gary Gallia, MD||Johns Hopkins University School of Medicine, Department of Neurosurgery|